Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03153488
• Other study ID #: 2017P000547
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 6-month trial in adults to find out if certain neuromarkers can predict individual treatment response to stimulant medications for Attention Deficit Hyperactivity Disorder (ADHD). Males and females, ages 18-45, will complete an MRI scan at MIT prior to beginning medication for ADHD as determined by a treating clinician outside the context of this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male and female adults ages 18-55

• A diagnosis of DSM-V ADHD based on clinical assessment supported by the ADHD module of a structured diagnostic interview

• Proficiency in English

• Right-handed

Exclusion Criteria:

• Any contraindication for the use of a stimulant medication

• Investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild)

• Any contraindications for MRI examination (metallic implants, such as pacemakers, surgical aneurysm clips, or known metal fragments in the body)

• Women who are currently pregnant or breastfeeding, as confirmed by a urine pregnancy test

• Clinically significant abnormal baseline laboratory values, including systolic and diastolic blood pressure parameters above 140 and 90, respectively and resting heart rate outside 60-100 bpm

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Radiation:
• MRI
All participants will perform one MRI session before initiation of treatment. The imaging session will last about an hour including the structural and functional MRI portions. The subjects lie on a padded scanner couch in a dimly illuminated room, and wear foam earplugs to attenuate scanner sounds.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Clinical Global Impressions Scale - Severity (CGI-S)	The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.	6 months
Primary	ADHD Clinical Global Impressions Scale - Improvement (CGI-I)	The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.	6 months
Secondary	Connectomic Variation Prediction of Medicine Response	Examine whether variation in baseline ADHD severity scores and functional connectivity and structural connectivity predict whether an individual ADHD patient will respond better to one of the other stimulant family treatment, both, or neither. An MRI will be completed prior to starting medication.	6 months